NCT00302835

Brief Summary

The objective of the international, multicenter case-control study was to evaluate the association between end-stage renal disease (ESRD) and use of non-phenacetin-containing analgesics with particular emphasis on combined formulations.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 15, 2006

Completed
Last Updated

April 24, 2006

Status Verified

April 1, 2006

First QC Date

March 14, 2006

Last Update Submit

April 21, 2006

Conditions

Kidney Failure, Chronic

Keywords

AnalgesicsChronic Kidney Failure

Interventions

non-phenacetin containing analgesicsDRUG

Eligibility Criteria

Age0 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Cases: Patients under the age of 50 years with new (incident) chronic ESDR during the study period in a given dialysis center.
  • Controls: Healthy persons from the same region the case came from and in the same 5-year age and gender group.

You may not qualify if:

  • Patients with acute or remittent renal failure (e.g. after renal transplantation), out of age range, dead before the interview could be done, bad physical or mental condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Epidemiology and Health Research

Berlin, 10115, Germany

Location

Related Publications (1)

  • Heinemann LA, Garbe E, Lewis M, van der Woude F, Graf H. Case-control study on analgesics and nephropathy (SAN): protocol. BMC Nephrol. 2005 Aug 8;6:9. doi: 10.1186/1471-2369-6-9.

    PMID: 16086834BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lothar AJ Heinemann, Professor

    Center for Epidemiology and Health Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 14, 2006

First Posted

March 15, 2006

Study Start

January 1, 2001

Study Completion

December 1, 2004

Last Updated

April 24, 2006

Record last verified: 2006-04

Locations

DE(1)